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Lung Tissue Mycobacteria Identification Detection Kit

 (Nucleic Acid Mass Spectrometry) 

CE-IVD


BACKGROUND

The incidence rate of lung diseases is increasing year by year, especially the high incidence of pulmonary infectious diseases and lung tumors, which seriously threaten human health and life safety. At present, lung biopsy and lung tissue samples are often performed only by pathological examination. Although pathological examination can identify most of the benign and malignant lesions, it is seldom applied to the diagnosis of infectious diseases. Clinical microbiological examination plays an indispensable role in infectious diseases diagnosis, medication guidance, hospital infection control, antimicrobial management etc. However, this field still faces major problems such as long sample circulation time. For example, in terms of microbial identification, although there are automatic calibrators, which relatively shortens the time, they are mostly based on the principle of microbial biochemical reaction, and still cannot achieve rapid identification. Therefore, clinical microbiology laboratory urgently needs new testing technology to replace the existing technology and achieve new breakthroughs.

DETECTION STRAIN

Strain NameAbbreviationsStrain NameAbbreviationsStrain NameAbbreviations

Mycobacterium 

Smegmati

MSM

Mycobacterium

 Triviale

MTR

Mycobacterium

Scrofulaceum

MSC
Mycobacterium KansasiMKA

Mycobacterium

 Vaccae

MUA

Gastric

 Mycobacterium

MXE

Marinum /

Mycobacterium 

Ulcerans

MMA/MUL

Mycobacterium

Diernhoferi

MDIMycobacterium PhleiMPH
Mycobacterium TerraeMTE

Mycobacterium

Neoaurum

MNE

Mycobacterium

Tuberculosis

MTB

Mycobacterium

Porcinum

MPO

Mycobacterium

Intracellulare

MIN

Mycobacterium

 Gastri

MGA
Mycobacterium AviumMAV

Mycobacterium

Chclonae Subsp

Chclonae

MCH

Mycobacterium

 Szulgai

MSZ

Mycobacterium Chelonei

Subsp Abscesses  

MAB

Mycobacterium

Fortuitum

MFO

Mycobacterium

 Simiae

MSI
Mycobacterium GilvumMGI

Mycobacterium

Nonchromogenicum

MNO

Mycobacterium

 Aurum

MAU

Mycobacterium 

Gordonae

MGO

Mycobacterium

Tuberculosis 

Complex

MTC


DETECTION METHOD 

Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) technology is used to extract nucleic acids from patients' lung tissues. DNA detection technology combined with PCR in vitro amplification and massarray mass spectrometry are used to qualitatively detect the extracted nucleic acids to identify some pathogenic mycobacteria and their subtypes and confirm whether the patient is infected with the microorganism to be tested.



IDENTIFICATION METHOD OF MYCOBACTERIUM SPECIES 

Comparison

Sputum Smear

Microscopy

Routine Culture +

Biochemical

Method

Rapid Culture

Method

Gene Chip Method

Nucleic Acid Mass

Spectrometry

SensitivityLowHighHighHighHigh
SpecificityLowLowHighHighHigh
RepeatabilityLowLowLowHighHigh

Clinical

significance

Tuberculosis and

non tuberculosis

cannot be

distinguished

A few identifiable

strains

Tuberculosis and

non tuberculosis can

be distinguished, but

strains cannot be

identified

Mycobacterium

tuberculosis

complex flora and 22

species can be

identified NTM

25 pathogenic

mycobacteria and

MTC can be

identifiedat one time



DETECTION SIGNIFICANCE

Accurately identify common clinical MTC and 25 pathogenic mycobacteria, and can distinguish between tuberculosis and non-tuberculous mycobacteria, clarify the etiology, and realize personalized treatment.


Product NameDetection MethodPack SizeInstruments ValidatedSample Type

Human Lung Tissue

Mycobacteria

Identification

Detection Kit

Nucleic acid mass

spectrometry

40 test/kit

MassARRAY®DNA mass

spectrometry gene

analysis system

Paraffin

embedded

 tissue



FEATURES & ADVANTAGES

1.Advanced technology: Combined with PCR technology to analyze the nucleic acid molecular level of pulmonary infection bacteria, there is no need for in vitro culture and other processes, reducing manual operation, simple and fast.Only one day for detection results. Large amount of data.

2.Large amount of data: 96 samples can be processed at the same time, and each sample can identify 25 different types or subtypes of pulmonary infectious bacteria at one time.

3.Good specificity: Can tolerate 100 ng wild-type human genomic DNA without non specificity.

4.High sensitivity: Mycobacterial nucleic acid DNA with content as low as 200 copies in 20 ng human genomic DNA can be detected.



DETECTION PROCESS 

1.Nucleic Acid Extraction

2.Sample Adding

3.Mass Spectrometry Detection

4.Data Analysis

5.Report